MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION NEUROMASTER G1; EVOKED RESPONSE ELECTRIC STIMULATOR (MAIN UNIT FOR MEE-2000)

Model Number	DC-200B
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the mee-2000a is disconnecting during exam.There was no patient injury reported.
Additional Manufacturer Narrative
The customer reported that the mee-2000a is disconnecting during exam.Technical support (ts) remoted in and verified the main unit settings and they seemed to be correct.The customer will send in the unit to be exchanged.There was no patient injury reported.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.Attempt # 1: 06/17/2022 emailed the customer via microsoft outlook for patient information: the customer replied by stating; they have not kept track of the patients having the procedure as there was no detriment to patient care.Concomitant medical products: the following device was used in conjunction with the mee-2000a: model #: dc-200ba.Serial #: (b)(4).Device manufacturer data: (b)(4).Unique identifier (udi) #: (b)(4).Returned to nihon kohden: (b)(4).
Additional Manufacturer Narrative
Details of complaint: the customer reported that the mee-2000a system was disconnecting during an examination.The device was not in patient use.Investigation summary: the reported device was sent in for an exchange and evaluation.During the evaluation of the returned device, nihon kohden repair center (nk rc) could not duplicate the reported issue of the device shutting down with multiple protocols.As such, a root cause could not be determined.A similar issue was reported in ticket 144023, on a different serial number, where the issue was resolved by turning off the option to store raw wave.The option was causing the unit to overload as it was storing each wave.As such, the cause of that issue was due to incorrect settings.A serial number review of the reported device does not reveal additional related complaints.The root cause is likely related to use error and settings.The following fields contain no information (ni), as an attempt to obtain the information was made, but not provided: attempt # 1: 06/17/2022 emailed the customer via microsoft outlook for patient information: the customer replied by stating; they have not kept track of the patients having the procedure as there was no detriment to patient care.
Event or Problem Description
The customer reported that the mee-2000a system was disconnecting during an examination.No patient harm was reported.
Event or Problem Description
The customer reported that the mee-2000a system was disconnecting during an examination.No patient harm was reported.
Additional Manufacturer Narrative
Udi related data quality updates.Corrected information: d1 brand name: corrected the brand name from mee-2000a to neuromaster g1.D4 additional device information / model #: corrected the model # from mee-2000a to dc-200b.D4 additional device information / catalog #: corrected the catalog # from mee-2000a to dc-200ba.D4 additional device information / primary unique device identifier (udi) #: corrected the udi # to include the production identifier (pi) information.This is a correction to the suspect medical device involved in the reported event, specifically the unique device identifier (udi) information in section d of the fda form 3500a.

• Brand Name: NEUROMASTER G1
• Common Device Name: EVOKED RESPONSE ELECTRIC STIMULATOR (MAIN UNIT FOR MEE-2000)
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 14738523
• Report Number: 8030229-2022-02947
• Device Sequence Number: 2226924
• Product Code: GWF
• UDI-Device Identifier: 04931921118054
• UDI-Public: (01)04931921118054(21)282
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K142624
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DC-200B
• Device Catalogue Number: DC-200BA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2022
• Supplement Date Received by Manufacturer: 12/08/2023; 12/08/2023
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 12/11/2023; 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DC-200B
• Patient Sex: Unknown